Biotechnology

Biotechnology holds the promise for new vaccines, pesticides, insect-resistant plants, bacteria that can break down toxic wastes, and genetic engineering. Safeguards are needed, however, to ensure that the release of organisms created by biotechnology does not pose an unreasonable risk to public health or the environment. The Toxic Substances Control Act (TSCA) was passed in 1976 to safeguard against the introduction of harmful new chemicals into the environment. The Environmental Protection Agency (EPA) considers microorganisms used in biotechnology products to be "chemical substances" and thus subject to regulation under the act. This report examines (1) EPA's efforts to issue a TSCA biotechnology regulation and (2) the impact on the biotechnology industry of not having a TSCA biotechnology regulation.

GAO found that: (1) EPA has worked since 1984 to issue a TSCA biotechnology regulation, but has been unsuccessful, primarily because of disagreement within the executive branch over the scope of the regulation; (2) in 1988, EPA developed a proposed regulation and sent it to the Office of Management and Budget (OMB) for review, but the Office of Science and Technology Policy (OSTP) raised concerns that the proposal would subject more microorganisms to regulation than was warranted by their probable risk to the environment, and EPA withdrew its proposal; (3) in July 1990, OSTP issued new guidance defining the scope of biotechnology products to be considered for regulation, and EPA completed a revised regulation based on the new guidance; (4) in February 1992, OSTP eliminated the definition of the scope of the 1990 guidance, and advised agencies to oversee the introduction of only biotechnology products that posed an unreasonable risk to the environment; (5) the guidance did not provide any specific direction on how agencies were to implement the risk-based approach, and it was unclear whether the proposed EPA regulation would be acceptable; and (6) the biotechnology industry is concerned that the extended debate over a final regulatory process inhibits investment in new biotechnology products.